Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer

NCT ID: NCT00491621

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2014-09-30

Brief Summary

Renal cancer is frequent and its diagnosis mainly dependant on imaging. More than 50% of renal tumors are currently diagnosed without symptoms. However, 20% of small solid tumors are benign and this percentage is much higher in atypical cystic tumors Bosniak II and III, where 76% and 59% are benign respectively. Determining the malignancy by imaging in these cases is difficult and sometimes impossible. The fine needle aspiration (FNA) cytology or biopsy is necessary. The diagnostic sensitivity and specificity with biopsy are high, but the potential tumor contamination is a major risk. The FNA cytology is simple and safe, but its sensitivity is about 50%. We are conducting a multicentric prospective study to add the molecular markers in FNA cytology as a new diagnostic method in imaging-indeterminate renal tumors.

Four molecular markers including MN/CA9, vimentin, KIT, and S100A1 will be studied. These four markers have been reported to have a differential diagnostic value in renal tumors. MN/CA9 and vimentin are often found in conventional renal cancers. KIT is frequently expressed in renal oncocytomas and chromophobe renal cancers. S100A1 may further distinguish renal oncocytoma from chromophobe renal cancer. These markers will be analyzed by real time polymerase chain reaction (RT-PCR).

The aim of this study is to evaluate the diagnostic performance of the association cytology-molecular markers in imaging-indeterminate renal tumors (small solid tumors and cystic tumors ≥ Bosniak III). About 156 patients will be included in five French clinical centers including Saint-Etienne, Marseille, Grenoble, Toulouse, and Nancy.

The expected results will improve the preoperative diagnostic accuracy in renal tumors.

Conditions

Kidney Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

surgery or biopsy of the kidney tumor

Group Type: OTHER

surgery or biopsy of the kidney tumor

Intervention Type: PROCEDURE

surgery or biopsy of the kidney tumor

Interventions

surgery or biopsy of the kidney tumor

surgery or biopsy of the kidney tumor

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of kidney tumor < 4 cm
• Cystic kidney tumor (Bosniak > IIF)
• Consent signed

Exclusion Criteria

• Benign tumor confirmed
• Impossibility to do abdominal pelvic ultra-sound or abdominal thoracic scanner
• Contraindication for renal puncture

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques TOSTAIN, PhD-MD

Role: STUDY_CHAIR

CHU de Saint-Etienne

Locations

CHU de Grenoble

Grenoble, , France

Hospices Civils de Lyon - Edouard Herriot

Lyon, , France

AP-HM Hôpital Nord

Marseille, , France

AP-HM Hôpital Salvator

Marseille, , France

CHU de Nancy

Nancy, , France

CHU de Saint-Etienne

Saint-Etienne, , France

CHU de Toulouse

Toulouse, , France

Countries

France

References

Li G, Cuilleron M, Cottier M, Gentil-Perret A, Lambert C, Genin C, Tostain J. The use of MN/CA9 gene expression in identifying malignant solid renal tumors. Eur Urol. 2006 Feb;49(2):401-5. doi: 10.1016/j.eururo.2005.10.025. Epub 2005 Dec 19.

Reference Type: BACKGROUND

PMID: 16387417 (View on PubMed)

Li G, Cuilleron M, Gentil-Perret A, Cottier M, Passebosc-Faure K, Lambert C, Genin C, Tostain J. Rapid and sensitive detection of messenger RNA expression for molecular differential diagnosis of renal cell carcinoma. Clin Cancer Res. 2003 Dec 15;9(17):6441-6.

Reference Type: BACKGROUND

PMID: 14695146 (View on PubMed)

Li G, Barthelemy A, Feng G, Gentil-Perret A, Peoc'h M, Genin C, Tostain J. S100A1: a powerful marker to differentiate chromophobe renal cell carcinoma from renal oncocytoma. Histopathology. 2007 Apr;50(5):642-7. doi: 10.1111/j.1365-2559.2007.02655.x.

Reference Type: BACKGROUND

PMID: 17394501 (View on PubMed)

Li G, Feng G, Gentil-Perret A, Genin C, Tostain J. CA9 gene expression in conventional renal cell carcinoma: a potential marker for prediction of early metastasis after nephrectomy. Clin Exp Metastasis. 2007;24(3):149-55. doi: 10.1007/s10585-007-9064-z. Epub 2007 Mar 28.

Reference Type: BACKGROUND

PMID: 17390110 (View on PubMed)

Li G, Gentil-Perret A, Lambert C, Genin C, Tostain J. S100A1 and KIT gene expressions in common subtypes of renal tumours. Eur J Surg Oncol. 2005 Apr;31(3):299-303. doi: 10.1016/j.ejso.2004.11.009.

Reference Type: BACKGROUND

PMID: 15780567 (View on PubMed)

Other Identifiers

0501106

Identifier Type: -

Identifier Source: org_study_id